Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients

NCT ID: NCT06532097

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-01-31

Brief Summary

It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.

Conditions

Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention group

Group of patients that received the digital intervention

Physical and behavioral smartwatch-based activation

Intervention Type: BEHAVIORAL

We used smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown large effects in the amelioration of depression.

Retrospective control group

Retrospectively collected group of patients from earlier versions (amendments) of the study who filled out the PHQ-9 twice with a certain interval (and were offered the intervention at a later time-point)

No interventions assigned to this group

Interventions

Physical and behavioral smartwatch-based activation

We used smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown large effects in the amelioration of depression.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Written consent for voluntary study participation
• Between 18 and 65 years of age
• Current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to ICD-10 (F32.0, F32.1)
• Internet access and email address to answer electronic questionnaires
• Ability to read German

Exclusion Criteria

• Acute suicidality
• Pregnancy and breastfeeding
• Currently undergoing psychological treatment
• Current use of psychotropic medication
• Neurological or internal medical disease
• Diagnosis of a severe major depression or dysthymia according to ICD-10 (F32.2, F32.3, F33.2, F33.3, F34.1)
• Diagnosis of a psychotic disorder according to ICD-10 (F20-F29) in the life history
• Diagnosis of a bipolar disorder according to ICD-10 (F31) in life history
• Acute substance abuse (e.g., drug use or excessive alcohol and nicotine use)
• Diagnosis of dissociative disorder (F44) in life history

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Max-Planck-Institute of Psychiatry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Spoormaker, PhD

Role: PRINCIPAL_INVESTIGATOR

Max-Planck-Institute of Psychiatry

Locations

Max Planck Institute of Psychiatry

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

MaxPlanckIP

Identifier Type: -

Identifier Source: org_study_id